MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problems Optical Problem (3001); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: sicu manager.(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab), the customer had questions regarding the arterial waveform and numbers.They then stated that the fiber optic cable hadn¿t been working.Troubleshooting revealed a prior fiber optic sensor failure.Balloon tip position was confirmed by the cardiologist.All cables and connections were verified to be secure.The customer aspirated the line getting back adequate blood return.The arterial waveform displayed with better augmentation.Maintenance practices and leveling were reviewed.There was no patient harm or adverse event reported.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

Event Description

N/a.

• Brand Name: UNKNOWN INTRA-AORTIC BALLOON
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 12823694
• MDR Text Key: 282566514
• Report Number: 2248146-2021-00757
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 100 KG